We are way beyond that. More work needed in the Oversight Framework as lamar mentioned the presence of Precision Medicine and what that is. The third area is strengthening our ability to carey out the mission. Mark couldnt be with us but talked about how important that is. We have a number of recommendations in the report relating to the fdas Human Resources and how do you hire people today. Many require collaboration with hhs and the office of personal management. We all know in government the hiring and firing and recruiting process happens in the legislatorive branch when legislati legislative branch needs to be investigated. We need to improve the publi publicprivate partnerships out there. And providing access to medical products and there is a Government Role and responsibility looking at the unmet needs that may not have a financial incentive for going there. The biggest, most important drug company in the world is not going there, scientist and researchers are not going there, but that is a specific role of government that the fda has a very important obligation response ability. And another area, lastly, i will call attention to is the need to acc accelerate the development of something that affects everybody in the room and that is the use of antibiotics. We know super bugs are an issue. We know people are dying from it. It is created by our use of other antibiotics. We need to accelerate innovation to cure it, treat, and the fda needs to give special attention to the use of antibiotics with the super bugs. That is enough. I went on way too long. Those are the four sections. Read the report and we can talk more about similar sections as we go through. Thank you, senator frist. As mentioned, there is a lot of recommendations in the executive summary and what we have on the webite is the combination of things in cure we hope the Senate Moves Forward with, things we would like to go further and one of them is around the use of real world evidence for postand premarket. And there a number of ideas not in the 21st century legislation. We have a nice, easy crosswalk for you. We will run through a couple topic areas. One that is important to us is about competitiveness of american companies. I wonder, representative gordon, if you might talk a little bit about that and how the reports improve the nations competitiveness and the country. Is this on . Maybe you have to turn it on. There you have. Well, let me just speak up then. You think we are excited about this report . I think for good reason. The best thing for me to say is amen. But following senators model when we worked on the america for pizza act we found after world war ii and the end of last century the United States led the world in all economic areas. We did that because of a simple formula. We invested in education having a Skilled Workforce and invested in research for new ideas, improved ideas and new services. And half of our gdp resulted from our investment in that research. So then comes this next century, and we are seeing a couple things happen. Our investments are starting to be stagnant or going down. And the rest of the world is increasing their investment. They read the book, they figured out what the secret was, and this is a quick example. In the area of rnd, in the pharmaceutical and medical device area, from 20072012 our share of the worlds investment went from 50 down and asia went from 16 to 23 . So we have to get our competitiveness back again. We talk about putting more money into the pot and that is one aspect of it. But if we can get more yause of the money we are spending you get the same results. A couple important areas is inter interoperability and i think in our report we give specific recommendations. And if you will see the government starts leading these areas, then that will be a Market Driver for other areas. Another thing i think that is going to be important and we have a unique time to do this is looking at interoperability and harmionization and mutual acceptance. We just got through passing fast track. Tpt is being worked on. Tchef is coming up after that. I think there are unique opportunities, whether it is through the agreement itself, or the vehicle to have these discussions to find out how can we have harmonization and mutual acceptance. It takes ten years and 2 billion to get a new drug on the market. Surely we can do better than that. Dr. Patrick, you have had a long history of developing and implementing new and innovative ways to battle cancer. The topic of Precision Medicine and one that is interesting and a passion for you. Can you talk about advancements in the area and implications for fda . How does the fda need evolve given all of the advancements in science . I think the issue you brought up about Precision Medicine and the opportunity to have this as a bipartisan event is so fantastic in terms of the timing. What i would like to do is maybe lay out, i spent 30 years of my life looking at this issue of cancer now as a problem, then leaving the University First nano particle for lung cancer. Through that event, i laid out the problem that scales out as we age. We have lost the war on cancer because we went with the wrong assumption. I will explain how Precision Medicine can save us and the urgency of what we need to do. We always assumed as a nation and society that cancer was a single chrome that happens in yourself and the single chrome grows and you would kill it. So for 40 years we have been going down this path of singledrug of maximum tolerated dose of chemo or radiation. It made sense if it was single we would try to kill it and save your normal cells by putting you through a horrible process hoping you come out with the chrome dead and your body alive. That assumption is made by a single mathematical calculation which in retrospect was in error that cancer cells grew linear. It turns out through next generation seck sequence there is thousands in the body. The body makes 10,000 cancer cells a day but the body has a protection method from letting them grow. So 10,000 chromes discovered through next Generation Sequencing and this idea of zapping the patient with a tolerated dose has failed because it killed that one cancer cells and those asleep come awake. So we went down this path and in 1990, 25 years ago, i wrote the first paper on this very ancient cell we have in our body called the natural killer cells that floats around in the body protecting your body from infection, ebola, cancer, and if we could harness that cell and cause that cell to kill the cancer you would find a new way in. But for 40 years we have been wiping out the same cell that is protecting us by giving us maximum tolerated dose of chemotherapy. There was a vaccine drug for breast cancer, a protein nano particle, and lung and pancriattic cancer and one of my jobs was to go explain to the hospitals of the world that we must stop this idea of maximum tolerated dose. I lost that argument, by the way. So i ran my own clinical protocol. So this is the wonders of america. I come from south africa as a physician and a surgeon and science. And that Company Became a multimillion company and i can pursue this idea. We gave lowdose chemotherapy and we have patients alive all the way as far as eight years alive without the disease wold normally be dead in two months. So the challenge then is how do we now change that. Once we acknowledge what we disb covered is one. Lets do sequencing now. There are 13 million cancer survivors out there in the country. We can identify the sequence and know which chrome not to hit. You need lowdose multiple forms of chemo that will stress the system and you can inject that into the blood and reverse that. Tomorrow, we are going public. In which the natural killer cell we want to launch. Most clinicians cannot understand the science meaning they need interoperable help too at the Electronic Medical record center. I came for 84 years and work that the 40 billion we would spend with Electronic Medical records. We are spending money on systems that will not talk to each other. A propriety system will not talk to each other. So you dont have the intelligence. How could you treat a patient with two months to live with information that could affect his or her life in real time . That is what we have put in place. This is the opportunity through system. The next question is how does equipment take the capacity for every human being to have the sequence known in real time. To know which drug to give. It will be a combination of drugs. Some owned by five different pharmaceutical companies. How will we regulate that . Who is going to prove giving that combination deserves funding . These are the challenges that face us and this is Precision Medicine and i am happy to say this has been a forefront and we have the capacity to go do this. Thank you, dr. Patrick. Before moving to q and a, mark, we have got a lot of recommendations in here about integrating the voice of the patient and helping them with access to needed treatments. Can you share about those and we will move to q and a after that. Sure. Thank you, janet. Let me touch on two issues near and dear to what we all hope to accomplish. Am i on now . All right. So, the National Health council is an Umbrella Organization of the nations leading advocating organizations. I want to speak to you in the audience and say that collectively the National HealthCouncil Members represents 133 Million People with one or more chronic diseases. That is more than 35 of the population here in the United States. So raising your hands, how many have someone in your immediate family or circle of friends with a chronic condition . Raise your hands. That is why we are all here today. I want to talk to you about two provisions that have been put forward in the recommendations with the overwhelming weight of the recommendations being huge. It creates the environment for us to develop highly needed, high value treatments for all of the people we care about in our families. The first issue i would like to speak about is patient engagement. It is ironic. But we have created a system where everybody speaks for the patient. The doctor speak for the patient, the researcher speak for the patient, and they are the surrogate for what is important to us. Their opinions are critically important. But when you ask them what is most important to the patient, and then you ask the patient,ia get a different answer. And it is ironic that we have built up a system that is created barriers to the bio pharmaceutical sector and the regulators to actually engage the patient. For a Bio Pharmaceutical Company to engage with patients, they could potentially be subjected to millions of dollars in fines for marketing an unapproved product. But everybody in the room has a smart phone. The developers of those products that you all have in your pocket would not change the color or feature of the phone without engaging the enduser first to understand how it would impact them. Yet we dont do that in the development of medications. Every major Bio Pharmaceutical Company spent more than 2 billion developing a product, brought to market, and realized it didnt answer the appropriate questio question. We are not invited to determine the Research Questions and when we are they go in a different way. We are not invited to determine what the patient reported outcomes should be. Think about that. Other people are deciding for us what are the most important outcomes. We should be part of that process. And there are great methods for doing this. We have a president who has been elected twice using these methods in the social sector. We dont use patients when we develop Clinical Trials and as a result we have a hard time p populating them and keeping people them in. Huge opportunities to shorten drug time by having participants in the development of Clinical Trial protocols. We are not involved in the determining of cost and benefit. The judgment the fda makes on risks and benefits is just that. A judgment informed by science but it ethically has the reflect the end user. It needs to be stratified to account for the individual patients determination of benefitrisk, their tolerance for the disease, their tolerance for existing treatments. Huge opportunities to get that information into the label that this is not a substitute for the current Regulatory Approval process. It is adding Additional Data that would go into the the labeling, come out at the back end, so that when i meet with my doctor and tell them what is important to me, they can determine from among multiply treatments which one will address what i want addressed. Huge opportunity. Huge consensus in the pharmaceutical sector. This is a huge opportunity for win, for congress to remove some barriers and encourage the fda to move forward in changing the culture to make this a reality. The second issue i would like to address deals with insuring that treatments for unmet medical needs a developed. They were first alluded to this. Legislation was introduced in the house with 90cosponsors. Senators bennett and hatch introduced legislation dealing with dormant therapies. Most people know you dont develop a medicine without a strong patent, the less known factor is many treatments, potenti potenti potentially as many as 80 dont qualify for a patent. If you look at alzheimers and guarantee it will impact the progression of the disease, something all of us want, you need to have a Clinical Trial that will last 15 years because the development of the disease takes too long. For a company to invest 2 billion for a treatment for alzheimers and only have a few years left to market it without generic competition means they abandon a promising product. We see companies leaving the autoimmune space, the prevention space in cancer, we have an opportunity to say, patent system works but we can provide an alternative pathway if you have a product that addresses an unmet medical need as defined by the fda and bring that forward. Huge opportunities for the senate to address huge issues for 130 Million People with chronic disesases. Thank you, mark. As we close the panel, senator, did you want to make Closing Remarks . Where do we go from here . I think we heard senator alexanders charge to us. In additional step, we initiated this as i mentioned with dr. Mcclellan about three and a half months ago being compared to 2013. We know by action and identifying the problems and action legislatively we can have fantastic results which is encouraging. And this could be a range black by overzelous. Dont do it. We know we cannot prevent this. Inexcusable. The administration is open to legislation, sent a signal and acted from the executive, and this argues a piece edge legislation. All of the stakeholders are not happy of this. I do want to close on that because the doctor forgot they had a great leader. I think they are being held back in the regenerating field. We welcome you feedback. Thank you, senator. We have this gentlemen here. And then if you could raise your hand. Thank you very much. That was a terrific set of presentations. With so many questions, how do we determine what has the staying power and becomes an innovation we can use . It is my understanding that part of the political aspects of this edge legislation are like the research for health and equality would be eliminated is a concern. So what is the mechanisms for determining what works well and what works best . Let me give an answer that is just sort of the Immediate Reaction and turn to my two colleagues. There is no singleanswer. The government approach of being able to analyze Health Services is not excusable to have any consideration of it disappearing. When 2. 3 billion helped services and we have no way to evaluate that from a government standpoint i think you are right. I think the answer is it has to be all of us. Not just the medical scientist. The political figures are the least to address it but they can be very effective listenors. And the patients, mark cant represent them all, but represents just about all of them, and that voice, ultimately i think in this day and time will be the most powerful voice there. I liken this to a Rural Community i grew up in with no electricity and water which is common. Most of my family died young and that is why i am a patient advocate. I had to go home and renovate the house. I didnt realize my mom wall papered the house, curtains up, carpet down, she was so good at the wall papering you had to rub the wall to find the switch. But i realized no one was going to buy this house. Our innovation eco system has not had a major update in 35 years. Science has changed dramatically. The recommendations in this report go long and far. The cumulative impact is you get a renovated house you can sell for top dollar. That is what we need for our innovation ecosystem. Please join me in thanking our panel. [applause] thank you to our leadership, cochairs and advisory committee. It is with great pleasure i announce our next speak, senator michael bennet. Since arriving in washington, he hasnt wasted a moment in the unrelenting fight to create good paying jobs for folks in colorado and restore fiscal responsibility to washington. He has emerged as an effective leader with a proven record of bringing people together and was a member of the Bipartisan Group of eight. Four democrats and four republicans that introduced with a bill to fix the broken cystine and stregthen security and provide a fair path to citizens for millions of undocumented immigrants. Senator bennet is an active member of the Senate Health